LAKE FOREST, Calif.—STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, yesterday announced that the U.S. Food and Drug Administration (FDA) has granted approval of the EVO/EVO+ Visian Implantable Collamer Lens for the correction of myopia and myopia with astigmatism. An estimated 100 million U.S. adults ages 21 to 45 who have myopia are potential candidates for EVO, a biocompatible implantable lens that corrects distance vision, the company said.

"Following FDA approval, prospective patients in the U.S. and their doctors may now consider EVO for achieving visual freedom from the limitations, ongoing maintenance and inconvenience associated with glasses and contact lenses,” said Caren Mason, president and CEO of STAAR Surgical. “Over one million EVO lenses have already been implanted by doctors outside the U.S. and 99.4 percent of EVO patients in a survey have stated they would have the procedure again. The EVO lens is additive, provides excellent quality of vision day and night, does not cause dry eye syndrome and is removable by a doctor, if ever so desired," Mason said.
 
"Sales of EVO lenses outside the U.S. increased 51 percent in 2021 and have more than doubled since 2018, which speaks to the increasing choice by patients and our surgeon partners for EVO as the premium and primary solution for refractive vision correction. Surgeons will be trained and certified for EVO, and begin implanting EVO in the coming days and weeks in select cities.
 
"Commercialization of EVO in the U.S. will begin immediately and be supported by a nationwide advertising, marketing and public relations campaign. We wish to express our great appreciation for the outstanding work of our esteemed principal investigator surgeons and their staffs who enrolled patients, implanted and conducted follow-up per the clinical trial protocol during the most challenging of times,” Mason said.
 
STAAR’s Implantable Collamer lenses have been used successfully by patients for more than 20 years globally, the company said. EVOs are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens.
 
Earlier versions of the Visian ICL lens in the U.S. required a preoperative peripheral iridotomy that is now eliminated with EVO, thereby optimizing patient comfort and time efficiency for both the surgeon and the patient. EVO offers a lens-based alternative for the correction/reduction of refractive error in people who currently use glasses and/or contact lenses for distance vision correction.
 
A U.S. multicenter, prospective clinical investigation confirmed the safety of the EVO family of myopia lenses. There are now more than 100 clinical papers available discussing the safety and efficacy of the Visian ICL family of lenses globally.
 
Scott D. Barnes, MD, chief medical officer of STAAR Surgical, noted that the EVO lens is different from LASIK. “The EVO lens is added to the patient’s eye through a relatively quick surgical procedure where there is no removal of corneal tissue. Moreover, the EVO lens is removable by a doctor if ever desired. Results from our recent U.S. clinical trial are consistent with the more than one million EVO lenses that have already been implanted around the world,” said Dr. Barnes.